NCT02225691

Brief Summary

This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled diabetes patients in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

August 22, 2014

Last Update Submit

November 19, 2014

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Keywords

type 1 diabetestype 2 diabetespaired testing

Outcome Measures

Primary Outcomes (1)

  • Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.

    6 months

Secondary Outcomes (1)

  • Proportion of patients who achieve good glycemic control (HbA1c≤7%)

    6 months

Other Outcomes (2)

  • Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire)

    6 months

  • Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire)

    6 months

Study Arms (2)

paired testing of blood glucose

EXPERIMENTAL

Patient will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Paired testing arm will undergo paired testing of blood glucose.

Device: Paired testing of blood glucose Accu-Chek®

control arm

NO INTERVENTION

Non-insulin patients will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Patients in the control arms will not undergo paired testing and will be managed as before.

Interventions

Paired testing of blood glucose Accu-Chek®DEVICE

Patients in the paired testing arms will undergo training on paired testing with Accu-Chek® Active blood glucose meters. The paired testing training would include (1) how and when (testing regimen) to perform paired testing, and (2) how to respond to paired testing readings via lifestyle modifications, self-adjustment of insulin dose and additional testing, if applicable. Please refer to Annex A for further details of the training.

Also known as: Accu-Chek® Active blood glucose meters
paired testing of blood glucose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with diabetes mellitus
  • HbA1c ≥ 8% measured within the a month prior to enrolment
  • Have not been performing SMBG on a regular (daily) basis within the 3 months prior to enrolment
  • Willing and able to use Accu-Chek® Active blood glucose meter to perform daily SMBG
  • Willing and able to complete participant questionnaires
  • Willing and able to visit the physician at month 3 and month 6
  • Provide informed consent prior to enrolling in the study

You may not qualify if:

  • Any retinopathy that required photocoagulation or retinal surgery in the 6 months prior to enrolment or that may require photocoagulation or retinal surgery during the study
  • Any clinically significant condition that required hospitalization in the last 2 months prior to enrolment or that may require hospitalization (e.g. elective surgery) during the study
  • Any clinically significant psychosis or cognitive impairment
  • Unlikelihood to comply or complete the study
  • Women who are pregnant, lactating or planning to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weiping Jia

Shanghai, 200233, China

Location

Related Publications (1)

  • Shen Y, Zhu W, Lu L, Lu F, Kan K, Bao Y, Zhou J, Jia W. Contribution of structured self-monitoring of blood glucose to self-efficacy in poorly controlled diabetes patients in China. Diabetes Metab Res Rev. 2019 Jan;35(1):e3067. doi: 10.1002/dmrr.3067. Epub 2018 Sep 24.

    PMID: 30144264DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Weiping Jia, MD, PHD

    Shanghai 6th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiping Jia, MD,PHD

CONTACT

＋8602164369181wpjia@sjtu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The director of the endocrinology and metabolism department of the Shanghai 6th People's Hospital

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 26, 2014

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

CN(1)